SIGNATURE ORTHOPAEDICS PTY LTD
45 clearances · 5 recalls · 3 adverse events · 2 inspections · aggregated across 2 source records
Scorecard
Events per device across the 10,207-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0 →
0 in the last 12 months
Higher volume than 83% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
10,207 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Logical | 111-12-5652 | LPH | 09348215001056 | 2 |
| Logical | 111-12-9135 | LPH | 09348215001292 | 2 |
| Simple Cup Inserter AG | 112-152-384 | LXH | 09348215039196 | 2 |
| Cemented TSI Stem System | 111-34-1104 | LZO | 09348215054533 | 1 |
| Cemented TSI Stem System | 111-34-1103 | LZO | 09348215054526 | 1 |
| Cemented TSI Stem System | 111-34-1105 | LZO | 09348215054540 | 1 |
| Cemented TSI Stem System | 111-34-1106 | LZO | 09348215054557 | 1 |
| Cemented TSI Stem System | 111-34-1102 | LZO | 09348215054519 | 1 |
| Cemented TSI Stem System | 111-34-1101 | LZO | 09348215054502 | 1 |
| Fusion Ceramic Head 28mm | 111-22-0511 | LZO MBL MEH | 09348215007836 | 1 |
| Fusion Ceramic Head 32mm | 111-22-0512 | LZO MBL MEH | 09348215007843 | 1 |
| Fusion Ceramic Head 36mm | 111-22-0513 | LZO MBL MEH | 09348215007850 | 1 |
| Fusion Taper Sleeve +2mm | 111-37-0007 | LZO MBL MEH | 09348215062156 | 1 |
| Fusion Taper Sleeve +4mm | 111-37-0003 | LZO MBL MEH | 09348215025854 | 1 |
| Fusion Taper Sleeve +6mm | 111-37-0008 | LZO MBL MEH | 09348215062163 | 1 |
| Fusion Taper Sleeve +8mm | 111-37-0004 | LZO MBL MEH | 09348215025861 | 1 |
| Fusion Taper Sleeve -2mm | 111-37-0006 | LZO MBL MEH | 09348215062149 | 1 |
| Fusion Taper Sleeve -4mm | 111-37-0001 | LZO MBL MEH | 09348215025830 | 1 |
| Fusion Taper Sleeve 0mm | 111-37-0002 | LZO MBL MEH | 09348215025847 | 1 |
| Genius Total Knee System | 121-07-3000 | JWH | 09348215020330 | 1 |
| Genius Total Knee System | 121-07-4004 | JWH | 09348215020309 | 1 |
| Signature Femoral Head | 111-152-621 | LPH MEH | 09348215001926 | 1 |
| World Knee System | 121-20-4310 | JWH MBH | 09348215032111 | 1 |
| World Knee System | 121-20-4210 | JWH MBH | 09348215032104 | 1 |
| World Knee System | 121-20-4110 | JWH MBH | 09348215032098 | 1 |
| World Knee System | 121-20-4510 | JWH MBH | 09348215032135 | 1 |
| World Knee System | 121-20-4710 | JWH MBH | 09348215032159 | 1 |
| World Knee System | 121-20-4910 | JWH MBH | 09348215032173 | 1 |
| World Knee System | 121-20-4810 | JWH MBH | 09348215032166 | 1 |
| World Knee System | 121-20-4610 | JWH MBH | 09348215032142 | 1 |
Showing 1–30 of 10,207Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3008262872 | SIGNATURE ORTHOPAEDICS PTY LIMITED | Sydney New South Wales, AU | VAI | |
| 3014763043 | Signature Orthopaedics Europe Ltd | Athlone Westmeath, IE | — |